title: Quality requirements for critical assay reagents used in bioanalysis of therapeutic proteins: what bioanalysts should know about their reagents.
abstract: Ligand-binding assays are the standard technology used for bioanalysis of therapeutic proteins, for example, for drug quantification (pharmacokinetics assays) and immunogenicity testing (antidrug antibody assays). Besides the selection of the most suitable technology platform (e.g., ELISA, electrochemiluminescence assays and surface plasmon resonance assays) and assay procedure, a pivotal prerequisite for good assay performance on any technology platform is the design, production and characterization of high quality reagents. To enable bioanalytical project support over the complete product life cycle, an appropriate long-term reagent supply is needed. This perspective describes our opinion on the requirements for generation and QC of critical reagents used in ligand-binding assays for drug quantification and antidrug antibody detection to enable high-quality assays and long-term supply, including reagent batch switches. The critical parameters during reagent design, production and long-term supply, along with the appropriate analytical methods for QC testing and appropriate certification, are discussed.
authors.affiliation: Department of Bioanalytics, R&D Protein Analytics, Biologics Research, Pharma Research and Early Development (pRED) Penzberg, Roche Diagnostics GmbH, Nonnenwald 2, 82377 Penzberg, Germany. roland.staack@roche.com
authors.forename: Roland F
authors.initials: RF
authors.lastname: Staack
authors.forename: Jan O
authors.initials: JO
authors.lastname: Stracke
authors.forename: Kay
authors.initials: K
authors.lastname: Stubenrauch
authors.forename: Rudolf
authors.initials: R
authors.lastname: Vogel
authors.forename: Julia
authors.initials: J
authors.lastname: Schleypen
authors.forename: Apollon
authors.initials: A
authors.lastname: Papadimitriou
mesh_terms: D000818:Animals; D002623:Chemistry Techniques, Analytical / Q000592:standards*; D006801:Humans; D007202:Indicators and Reagents / Q000737:chemistry / Q000302:isolation & purification / Q000592:standards; D011506:Proteins / Q000378:metabolism* / Q000627:therapeutic use*; D011786:Quality Control
chemical_list: D007202:Indicators and Reagents; D011506:Proteins